In the pharmaceutical and food industries, there is a need to establish that products intended for human health administration or for human consumption are sterile or free from microbial contamination to assure that they are acceptable for their intended uses. Methods and apparatus currently employed for these purposes typically involve withdrawing a sample of a product from its container using a syringe. If the product to be tested is in solid form such as a powder, discrete particles, and the like, a sterile liquid is first injected into the container to suspend or dissolve the product before it is withdrawn for testing. Generally, multiple product samples are individually collected from separate containers and placed in a separate sterile vessel to which additional sterile liquid may be added as needed. This method of sterility testing requires numerous manipulations, each of which increases the risk of contaminating the samples regardless of the care taken in performing each manipulation.
It is inherent in these types of sterility testing that microbes are introduced during the test which may not be distinguishable from those that may be present in the product being tested. Such microbial contamination can be introduced into the product by the environment in which the test is conducted, the test equipment utilized and the personnel performing the tests. A test result is considered to be "false positive" when it reveals the presence of contaminating microbes when none, in fact, are present in the product being tested. Using currently accepted methods and apparatus to conduct sterility testing can result in obtaining "false positive" readings which can translate into significant loss of labor, time, effort and product.